Associate Quality Assurance

Quality Assurance Associate

Location: Tarzana, CA 91356 Duration: 08 months Pay Rate: $35.00/HR Working Days/Hours: 9 AM - 5 PM Sunday- Thursday OR Monday-Friday (possible weekend work)

Job Description:

Associate Level ~1+ year industry experience Must have:

• Basic understanding of GMP/GDP
• Experience working in a regulated manufacturing environment

Exposure to: Deviations (supporting or drafting minor ones) Keywords/experience:

• Deviations, CAPA, investigations
• Batch record review
• QA vs manufacturing distinction
• GMP/GDP application (not just mention)

Motivated by:

• Science and cell therapy
• Contributing to patient outcomes
• Career growth

Position Summary:

The client is seeking an energetic and experienced individual with a cell therapy quality assurance background to join our Quality Assurance (QA) team. The successful candidate will contribute to the advancement of our product pipeline by performing QA batch record review, label review and verifications, document archival of records, and other assigned tasks. You will also be expected to independently organize and manage timelines for batch record reviews. Responsibilities include, but are not limited to:

• Reviews routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closure.
• Review routine material release documentation for quality release of raw materials used for manufacturing and quality control testing.
• Work with Doc Control to ensure archival of batch records.
• Work with QA doc control to ensure accurate issuance of batch record documentation (i.e., lot/media records and labels) to manufacturing.
• Provide quality assurance support across technical operations functions (i.e., Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, Product Development/Manufacturing Sciences & Technology) within AZ to assure compliance with the quality manual and maintain collaborative quality relationships.
• Perform other duties as requested by supervisor/manager to support Quality.
• Administrative Tracking of QA Metrics
• On the Floor QA support

Qualifications:

• Associate's degree with 1-2 years of experience in Quality Assurance or GMP experience
• OR High School diploma with at least 3 years of Quality Assurance or GMP experience
• Basic GMP knowledge
• Batch Record Experience
• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
• Flexibility of occasionally working on weekends or holidays to support the lot release.
• Demonstrated ability to take ownership, initiative, and self-accountability.
• Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced, dynamic team setting.
• Attention to detail and quick learning/application of concepts and information.
• Knowledge of cell culture techniques and proficient in MS Word, Excel, PowerPoint, and other applications.
• Ability to communicate and work in a self-guided manner with scientific/technical personnel.

Preferred Qualifications:

• An MA/MS in Biology, Chemistry, Microbiology, Engineering, or a related field is required, or a BA/BS with 2+ years
• Experience in Cell or Gene Therapy
• Well-versed in various cell therapy manufacturing processes